This series of bite-sized episodes will take you through the latest information regarding disrupted nighttime sleep and its relationship to cardiovascular risk, plus patient/clinician preferences regarding the treatment of narcolepsy with sodium oxybates.
Oxybates: 1 Molecule, 3 Formulations – Safety
Oxybates: 1 Molecule, 3 Formulations – Safety
Welcome to CME on ReachMD. This episode is part of our MinuteCME curriculum.
Prior to beginning the activity, please be sure to review the faculty and commercial support disclosure statements as well as the learning objectives.
This is CME on ReachMD, and I’m Dr. Michael Thorpy. Here with me today is Dr. Clete Kushida.
We’ve talked about the 3 different agents that are available for the treatment of narcolepsy that all contain oxybate. Two of them are twice-nightly formulations, and one is a once-nightly formulation. And we heard about the efficacies, which is showing that they’re efficacious for cataplexy and excessive daytime sleepiness, and also improve nighttime sleep. But how about the safety, Clete? Can you tell us a bit about the safety information from the clinical trial data?
Sure, Michael. So one of the more common types of adverse reactions that have been noticed in adults with greater than or equal to 5% were things like nausea, headache, dizziness, also vomiting, somnolence, bed-wetting, and tremors. So these are some typical adverse reactions that might occur in low frequency in these patients when they’re compared, at least twice the incidence with placebo.
Things that we always kind of are concerned with these class of medications are things like CNS depression. So we always want to make sure that when these medications are taken, it’s not coupled with another central nervous system depressant. And then, you know, sleepiness in the daytime can be a carryover effect. So we would always want to counsel patients against hazardous activities like if they have to go on a long drive or where, you know, they have to be very mentally alert at their job or other type of positions where they might be in hazardous situations.
So the sleepiness is an issue, and then another thing that we also keep in the back of the mind is depression. So in some patients, there have been depression as well as some suicidality, so that’s something to keep in mind. And then sleepwalking can occur. It’s not that frequent, but it can occur in certain patients. And lastly – and we’ll be talking about this later – is that given the sodium content, it’s not really a cause of concern, but it is something to look at in specific classes of patients.
Thank you, Clete. So these 3 medications have very similar symptoms or adverse effects, don’t they? And so overall, oxybate is very safe when taken in the prescribed manner. In general, the side effects tend to occur when you initiate the treatment, in the first couple of weeks of treatment, and the one that tends to come on a bit later seems to be that enuresis, and that often increases with the highest dose. But we have to bear in mind these clinical trials. And in the clinical trials, they weren’t able to advise the patients about other measures to take to reduce that enuresis. For example, what we clinically do is to ask patients to reduce the amount of fluid intake before going to bed and also make sure that they go to the bathroom before they take the medicine at night, and that tends to lessen the enuresis that was seen in the clinical studies.
Well, this has been a great bite-sized discussion. Unfortunately, our time is up. Thank you for listening.
You have been listening to CME on ReachMD. This activity is provided by Prova Education and is part of our MinuteCME curriculum.
To receive your free CME credit, or to download this activity, go to ReachMD.com/Prova. Thank you for listening.
In accordance with the ACCME Standards for Integrity and Independence, Global Learning Collaborative (GLC) requires that individuals in a position to control the content of an educational activity disclose all relevant financial relationships with any ineligible company. GLC mitigates all conflicts of interest to ensure independence, objectivity, balance, and scientific rigor in all its educational programs.
Michael J. Thorpy, MD
Director, Sleep‐Wake Disorders Center
Montefiore Medical Center
Professor of Neurology, Albert Einstein College of Medicine
Consulting/Advisory Board: Alkermes, Avadel Pharmaceuticals, Axsome, Balance Therapeutics, Eisai Pharmaceuticals, Harmony Biosciences, LLC, Idorsia Pharmaceuticals, Jazz Pharmaceuticals, NLS Pharmaceuticals, Suven Life Sciences Ltd., Takeda Pharmaceutical Co., Ltd, XW Pharma
Clete A. Kushida, MD, PhD
Professor, Division Chief
Medical Director, Sleep Medicine
Stanford University School of Medicine
Consulting Fees: XW Pharma
Research: Avadel Pharmaceuticals
Ann Marie Morse, DO
Director, Child Neurology and Pediatric Sleep Medicine
Geisinger Medical Center
Janet Weis Children’s Hospital
Consulting Fees: Alkermes, Avadel Pharmaceuticals, Jazz Pharmaceuticals, Harm Reduction Therapeutics, Takeda Pharmaceutical Co.
Research: Geisinger Health Plan, Jazz Pharmaceuticals, NIH, UCB,
Other: Damm Good Sleep, LLC
Franz H. Messerli, MD
Professor of Medicine
University of Bern
No relevant relationships reported.
- Jennifer Brutsche has nothing to disclose.
- Cindy Davidson has nothing to disclose.
- Elizabeth Lurwick has nothing to disclose.
- Andrea Mathis has nothing to disclose.
- Tim Person has nothing to disclose.
- Robert Schneider, MSW, has nothing to disclose.
- Peer Review, if applicable, Brian P. McDonough, MD, FAAFP, has nothing to disclose.
After participating in this educational activity, participants should be better able to:
- Evaluate the efficacy and safety of available sodium oxybate therapies in improving outcomes for patients with narcolepsy
- Describe the quality-of-life impact and potential cardiovascular effects of disrupted nighttime sleep on patients with narcolepsy
- Compare and contrast various federal and medical society guidelines, as well as clinical trial data, as to what constitutes appropriate sodium intake
- Define the counseling processes by which patients and clinicians can communicate about goals of treatment and implement shared decision-making as to the therapeutic management approach
This activity is designed to meet the educational needs of sleep medicine specialists, psychiatrists, and neurologists.
In support of improving patient care, Global Learning Collaborative (GLC) is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.
Global Learning Collaborative (GLC) designates this enduring activity for a maximum of 1.0 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Global Learning Collaborative (GLC) designates this activity for 1.0 nursing contact hour. Nurses should claim only the credit commensurate with the extent of their participation in the activity.
Prova Education designs and executes continuing education founded on evidence-based medicine, clinical need, gap analysis, learner feedback, and more. Our mission is to serve as an inventive and relevant resource for clinical content and educational interventions across a broad spectrum of specialties.
Prova Education's methodology demonstrates a commitment to continuing medical education and the innovative assessment of its effects. Our goal is clear—to develop and deliver the very best education in the most impactful manner and to verify its results with progressive outcomes research.
This activity is supported by an independent educational grant from Avadel Pharmaceuticals.
The views and opinions expressed in this educational activity are those of the faculty and do not necessarily represent the views of GLC and Prova Education. This presentation is not intended to define an exclusive course of patient management; the participant should use his/her clinical judgment, knowledge, experience, and diagnostic skills in applying or adopting for professional use any of the information provided herein. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patients’ conditions and possible contraindications or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities. Links to other sites may be provided as additional sources of information. Once you elect to access a site outside of Prova Education you are subject to the terms and conditions of use, including copyright and licensing restriction, of that site.
Reproduction of this material is not permitted without written permission from the copyright owner.
Our site requires a computer, tablet, or mobile device and a connection to the Internet. For best results, a high-speed Internet connection is recommended (DSL/Cable/Fibre). We also recommend using the latest version of your favorite browser to ensure compliance with W3C standards, such as Chrome, Safari, Firefox, or Microsoft Edge.